Accelerated approval might soon be in the cards for COVID-19 vaccines if an immune correlate of protection can be identified through ongoing work by FDA and NIH. Meanwhile, to speed more vaccines to Americans, FDA is trying to help ramp up manufacturing. Sanofi is set to commence a Phase IIb trial with an active comparator. 

Citing difficulties in conducting randomized trials, industry speakers call for a new way of thinking about the US FDA's substantial evidence standard for antifungal approvals under the LPAD route, as well as revisions to enrollment criteria and study endpoints.

A $60.8m financing round gives F2G the resources to develop what it hopes will be the first new antifungal in a new class in two decades.

Companies developing antibiotics to get financial and technical support from more than 20 firms contributing to new AMR Action Fund. Initiative is also pushing for reimbursement reform and other policies to support commercial marketing.